🇺🇸
United States · US · US:50580-338_490ec903-14a6-e576-e063-6294a90a6d13
IMODIUM
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1150580338061 BLISTER PACK in 1 CARTON (50580-338-06) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338122 BLISTER PACK in 1 CARTON (50580-338-12) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338183 BLISTER PACK in 1 CARTON (50580-338-18) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338614 BLISTER PACK in 1 CARTON (50580-338-61) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338644 BLISTER PACK in 1 CARTON (50580-338-64) / 6 TABLET in 1 BLISTER PACK
Annotations
Orange Book
N021140
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"ecb91e47-2b0c-47c8-9256-4623d8bc825e": {
"match": "brand_token",
"title": "IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [KENVUE BRANDS LLC]",
"spl_version": "23",
"published_date": "2026-01-30"
}
},
"productid": "50580-338_490ec903-14a6-e576-e063-6294a90a6d13",
"productndc": "50580-338",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "021140",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "Nov 30, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "IMODIUM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021140",
"marketing_category": "NDA",
"nonproprietary_name": "loperamide hydrochloride and dimethicone",
"start_marketing_date": "20080701",
"active_numerator_strength": "125; 2"
}Related drugs
Other records sharing ATC code P03AX.
- 🇺🇸ABC Arbonne Baby Care Diaper RashArbonne International, LLC
- 🇺🇸AD Treat Diaper Rash Cream with Dimethicone and Zinc OxideWellSpring Pharmaceutical Corporation
- 🇺🇸ADVANCED ANTACID MINTGOODSENSE
- 🇺🇸ADVANCED REGULAR STRENGTH ANTACIDWALGREEN COMPANY
- 🇺🇸Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchBayer HealthCare LLC.
- 🇺🇸Alka-Seltzer Kids Tummy ReliefChewsBayer HealthCare LLC.
- 🇺🇸ALMACONE DOUBLE STRENGTHRUGBY LABORATORIES
- 🇺🇸Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeRising Pharma Holdings, Inc.
Access this data programmatically
Query IMODIUM and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.